MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Model Number	309572
Medical Device Problem Code	Fungus in Device Environment (2316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle had mold on it.This was discovered before use.The following information was provided by the initial reporter: material no.309572 batch no.9203066.It was reported that mold was noticed on luer lok syringes when dispensing the syringes to a consumer.Pharmacist called to report mold on luer lok syringes (1) full box of individually wrapped syringes.Stated that she was dispensing the syringes to a consumer when she noticed the mold.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see section h.10.
Event or Problem Description
It was reported that bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle had mold on it.This was discovered before use.The following information was provided by the initial reporter: material no.309572 batch no.9203066 it was reported that mold was noticed on luer lok syringes when dispensing the syringes to a consumer.Pharmacist called to report mold on luer lok syringes (1) full box of individually wrapped syringes.Stated that she was dispensing the syringes to a consumer when she noticed the mold.

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9395517
• Report Number: 1213809-2019-01194
• Device Sequence Number: 524122
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: 30382903095729
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: 309572
• Device Catalogue Number: 309572
• Device Lot Number: 9203066
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other